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Multi-Target Stool DNA Test: A New High Bar for Noninvasive Screening

机译：多目标凳DNA检测：非侵入性筛选的新标准

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摘要

Stool DNA testing has evolved into what is now a highly accurate and well-validated test for the screen detection of colorectal neoplasia. An optimized and automated multi-target stool DNA test (MT-sDNA) has achieved the same high point-sensitivities as reported for colonoscopy and significantly higher sensitivity than by fecal immunochemical blood testing for detection of early-stage cancer and advanced precancer. Thus, MT-sDNA sets a new high criterion standard for the noninvasive screen detection of colorectal neoplasia. With clinical application, MT-sDNA has potential to meaningfully address current gaps in our approach to CRC screening through benefits of its high accuracy on screening effectiveness, user-friendly features on patient compliance, and easy mail-out distribution on test access. The US Food and Drug Administration and Center for Medicaid and Medicare Services have recently completed their parallel reviews of MT-sDNA, which has just become available for clinical use. This review summarizes the recent clinical validation data on MT-sDNA, addresses central clinical questions at this front end of implementation, and touches on innovative future applications of stool DNA testing.
机译：粪便DNA测试已经发展成为如今用于筛查大肠肿瘤的高度准确且经过充分验证的测试。经过优化和自动化的多目标粪便DNA测试（MT-sDNA），已达到与结肠镜检查相同的高点敏感性，并且比粪便免疫化学血液测试检测早期癌症和晚期癌症的敏感性更高。因此，MT-sDNA为非侵入性筛查结直肠瘤形成了新的高标准标准。在临床应用中，MT-sDNA具有筛查效果的准确性高，对患者依从性友好的用户友好特性以及易于在测试通道中进行邮寄分发的优势，从而有可能有效地解决我们CRC筛查方法中的当前差距。美国食品药品监督管理局以及医疗补助和医疗保险服务中心最近完成了对MT-sDNA的平行审查，该审查刚刚可用于临床。这篇综述总结了最近关于MT-sDNA的临床验证数据，在实施的前端解决了主要的临床问题，并涉及了粪便DNA检测的创新性未来应用。

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